Quality Assurance Engineer I

Job Description

Job Description

About the Role

We’re seeking a Quality Assurance Engineer I to support critical Quality Management System functions within our manufacturing operations. This role is ideal for an early career engineer looking to make an immediate impact in a fast-paced medical device environment. You’ll help manage supplier quality, drive corrective actions, support compliance, and contribute to continuous improvement initiatives that directly influence patient outcomes.

Key Responsibilities

Support production teams on all manufacturing-related quality needs

Administer supplier management processes

Coordinate equipment calibration and preventive maintenance tracking

Manage CAPA documentation, follow-up, and closure

Maintain training compliance records

Enter and track customer complaints in accordance with regulatory requirements

Support quality metrics reporting and system activity tracking

Identify and implement process improvement opportunities

Assist with documentation simplification, workflow charts, data analytics, and general administrative support

Perform other quality engineering tasks as assigned

Qualifications

Minimum Requirements

Bachelor’s degree in engineering (preferably Mechanical or Biomedical) from an accredited institution

Experience in the medical device industry (21 CFR 820 or ISO 13485); internships or project work in quality, manufacturing, or product development preferred

Key Competencies

Ability to interpret technical drawings and specifications

Strong analytical thinking and problem-solving skills

Excellent verbal and written communication

Comfortable working in a fast-paced, dynamic environment

Proficient in Microsoft Word and Excel

Strong collaborator with a “do the right thing” mindset—unafraid to surface and address quality concerns

Meticulous attention to detail, particularly with documentation

Working knowledge of programming languages (Python, JavaScript, SQL, or Visual Basic) a plus

Why Join Us?

This is a unique opportunity to grow your engineering career within a highly innovative medical device organization. You’ll gain exposure across operations, quality systems, and continuous improvement while helping deliver life-changing solutions to our customers.